KHR · Absorber, Saliva, Paper
Dental · 21 CFR 872.6050 · Class 1
Overview
| Product Code | KHR |
|---|---|
| Device Name | Absorber, Saliva, Paper |
| Regulation | 21 CFR 872.6050 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
Identification
A saliva absorber is a device made of paper or cotton intended to absorb moisture from the oral cavity during dental procedures.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K980783 | SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 | Irt Management Corp. | Apr 21, 1998 | SESE |
| K954068 | GENERAL HYGIENE KIT | Physician Industries, Inc. | Nov 8, 1995 | SESK |
| K953812 | GAUZE SPONGE | Remington Medical, Inc. | Oct 2, 1995 | SESE |
| K891054 | NON-STERILE GAUZE SPONGE | Dispomed, Inc. | May 1, 1989 | SESE |
| K891354 | ORTHODONTIC COTTON ROLL HOLDERS | American Orthodontics | Apr 17, 1989 | SESE |
| K890734 | DRY TIPS | Microcopy, Div. Neo-Flo, Inc. | Mar 10, 1989 | SESE |
| K870383 | ALGINATE WOOL FIBER | Adri | Apr 30, 1987 | SESE |
| K850988 | BOVO MOISTURE GUARD | E.H. Medical Co. | Apr 16, 1985 | SESE |
| K780400 | DEN-Z-ORB | Nice-Pak Products, Inc. | Mar 27, 1978 | SESE |
| K771908 | ISO-SHIELD SALIVA ABSORBERS | 3M Company | Nov 7, 1977 | SESE |
Top Applicants
- 3M Company — 1 clearance
- Adri — 1 clearance
- American Orthodontics — 1 clearance
- Dispomed, Inc. — 1 clearance
- E.H. Medical Co. — 1 clearance
